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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problem Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2022
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in siena, italy.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a short circuit of the cooling compressor; each time the device is powered up, the mains circuit of the hospital is tripped.The unit was removed from service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received a report that a heater-cooler system 3t device tripped the mains circuit of the hospital during priming.There was no patient involvement.
 
Manufacturer Narrative
Through the follow-up communication, livanova learned that the disinfection process is followed as per instructions for use by the customer, using puristeril 340 and hydrogen peroxid.The customer uses filtered water using pall filters as per instructions for use.Based on investigation results for similar events, the root cause of the reported issue was traced back to a wearing of the cooling coil leading to a refrigerant leak and water entering the refrigeration cycle damaging the compressor.The compressor failure leads to an increase in the leakage current of the device and the circuit breaker trips.
 
Event Description
See initial report.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80939
GM   80939
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key15904747
MDR Text Key306519145
Report Number9611109-2022-00629
Device Sequence Number1
Product Code DWC
UDI-Device Identifier04033817901099
UDI-Public(01)04033817901099(11)190116
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-80
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/03/2022
Initial Date FDA Received12/02/2022
Supplement Dates Manufacturer Received01/08/2023
Supplement Dates FDA Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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